Clincosm LogoSign in Get a demo

Sodium Bicarbonate for Acute Peripheral Vertigo

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05676216
Collaborator
(none)
225
Enrollment
3
Arms
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Vertigo is defined as the hallucination of spinning sensation or rotatory movement and is frequently combined with severe nausea and vomiting. In Taiwan, an average of 3.13 cases per 100 persons suffer from acute vertigo attack per year. And 1 in 3 patients with vertigo will have recurrent attack within a year. The sensation of disequilibrium and severe nausea and vomiting urge patients visit emergent department (ED) for help. Therefore, vertigo is one of the most common complaints in ED.

Vertigo can be divided into central type and peripheral type. Central type vertigo included life threatening disease like brainstem hemorrhage or infraction. Although peripheral vertigo is mostly benign, the acute symptoms relief are usually needed. The first line therapy of acute peripheral vertigo is using antihistamine or benzodiazepine with other anti-emetic agents. However, these agents usually have side effects of fatigue and lethargy, which will cause increasing patients' length of stay or elders' risk of falling.

Sodium bicarbonate is widely used in treating hyperkalemia or metabolic acidosis. Its safety and no side effect have also been proved. There were few reports of using sodium for treatment of acute vertigo in Taiwan and Japan. However, there is no strong evidence of comparing this therapy with other medication.

This study hypothesized that there is an equivalence of efficacy between sodium bicarbonate and diphenhydramine for treatment of vertigo. Using sodium can cause less fatigue or lethargy and can decrease ED length of stay. This study aims to perform a double-blinded randomized controlled trial to evaluate the efficacy of sodium bicarbonate for treatment of acute peripheral vertigo.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
225 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Sodium Bicarbonate for Treatment of Acute Peripheral Vertigo: A Double-blinded Randomized Control Trial
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Diphenhydramine

Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping

Drug: Diphenhydramine
Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping when vertigo patients visit Emergency Department
Experimental: Sodium Bicarbonate

Sodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping

Drug: Sodium Bicarbonate
Sodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping when vertigo patients visit Emergency Department
Experimental: Diphenhydramine with Sodium Bicarbonate

Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping with Sodium bicarbonate 66.4 mEq intravenous push

Drug: Diphenhydramine + Sodium Bicarbonate
Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping with Sodium bicarbonate 66.4 mEq intravenous push when vertigo patients visit Emergency Department

Outcome Measures

Primary Outcome Measures

  1. Reduction in vertigo intensity [Baseline and 60 minutes after drug administration]

    Reduction in Vertigo Visual Analog Scale (VAS 0~10, higher scores mean higher intensity) from baseline

Secondary Outcome Measures

  1. Reduction in nausea intensity [Baseline and 60 minutes after drug administration]

    Reduction in Nausea Visual Analog Scale (VAS 0~10, higher scores mean higher intensity) from baseline

  2. Improvement of ambulatory ability [Baseline and 60 minutes after drug administration]

    Change in objective ambulatory ability (score 1~4, higher scores mean a worse outcome) from baseline

  3. Lethargy [60 minutes after drug administration]

    Lethargy score (score 1~4, 1 indicates no lethargy and 4 indicates very lethargy)

  4. Emergency Department staying time [up to 24 hours]

    From patients admit to Emergency Department until patients discharge (up to 24 hours)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients with acute onset vertigo
Exclusion Criteria:

  • Pregnancy

  • First vertigo episode over 24 hours

  • Using any anti-vertigo medicine after onset

  • Drug allergy to Sodium bicarbonate or Diphenhydramine

  • Diagnosed with central vertigo

  • Heart failure NYHA class >1

  • Chronic kidney disease (CKD) stage ≥ 3

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

  • Principal Investigator: Chien-Yu Chi, MD, Emergency Department, National Taiwan University, Yunlin Branch

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05676216
Other Study ID Numbers:
  • 202209092MIND
First Posted:
Jan 9, 2023
Last Update Posted:
Jan 9, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by National Taiwan University Hospital
Sodium Bicarbonate
Diphenhydramine
Additional relevant MeSH terms:
Vertigo
Dizziness
Diphenhydramine
Promethazine

Study Results

No Results Posted as of Jan 9, 2023